Duns Number:654386890
Device Description: This instrument is used to measure the spherical refractive-power, cylindrical refractive This instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis.KR-9600 Measuring fuction include refractive and keratometer measurement.KR-9600 Auto ref/keratometerFashionable design and perfect in detailsEquipped with ARM Cortex-A8 processor, facilitating fast calculationsUpgraded refractive and keratometry measurement technique, providing more comprehensive image analyzingElectric chin rest lifting, automatic tracing and focusing(Y axis) provides mor intellectual operation7 inch touch screen with adjustable angle and ergonomic structure design
Catalog Number
-
Brand Name
AUTO REF/KERATOMETER
Version/Model Number
KR-9600
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HKO
Product Code Name
Refractometer, Ophthalmic
Public Device Record Key
67901a86-965d-425c-a7d0-7da0214857fc
Public Version Date
December 21, 2020
Public Version Number
3
DI Record Publish Date
December 02, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |